Local Heptagon Partners have an in-depth knowledge of hospital institutions and opinion leaders in various therapeutic areas, their past clinical trial records and their reputation in achieving their enrolment objectives. We would be happy to discuss a shortlist of possible sites with you or to run the appropriate feasibility questionnaires.
Besides European regulations, each country/site often has specific regulations, standard procedures and document templates. Local Heptagon Partners will help you save time and money as they are familiar with local provisions, language and customs while meeting your corporate requirements.
Upon receipt of the EudraCT number, we will support you in preparing the documentation packages required by the applicable Competent Authorities and Ethics Committees. For instance, carrying the EU provisions into the local documentation (i.e. ICFs) is no secret for our expert partners at Heptagon.
Achieving site objectives and a successful site management are subject to quality level of the PSV and SIV. These visits must be carried out by a qualified CRA. The years of experience of Heptagon Partners will provide the ultimate assurance for a careful site assessment and an effective initiation.
This may look as a routine job for a CRA. But only reliable and dependable clinical scientists will be able to follow your instructions autonomously on the long term: this is the job for freelance senior partners.
As a medium size company, you need a direct contact with the sites and the field monitors, avoiding plethoric fixed costs. Freelance and experienced scientists will be the link between you and all local actors in the country -site, regulatory- just for the time of the task. And why not saving on intermediaries?